Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assist… (NCT06119568) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance Assessment of a First Four Arms on Demand Open Robotic Solution for Assisted PN, RN and RP
Spain15 participantsStarted 2023-11-01
Plain-language summary
The purpose of this clinical investigation is to evaluate the safety and performance of the Bitrack System and its corresponding ElectroSurgical Endoscopic (ESE) instruments and Non-ElectroSurgical Endoscopic (NESE) instruments and accessories in patients with the indication of a robot assisted laparoscopic Radical Nephrectomy (RN), Partial Nephrectomy (PN) or Radical Prostatectomy (RP), as applicable. HYROS-PRnP is a confirmatory study in which the hypothesis of the primary endpoint is that the ESE/NESE instruments perform as intended when controlled by Bitrack System which operates exclusively under surgeon's orders. The study shall refer to safety and performance of Bitrack System together with its accessories and corresponding ESE/NESE instruments. This study includes the data collected up to 30 days post-surgery and provides the evidence that the tested medical devices fulfill the GSPR.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Adult subjects between 18 and 90 years old who have provided written informed consent prior to any clinical investigation related procedures.
✓. Subjects who have been scheduled for a laparoscopic Radical/simple Nephrectomy surgery, laparoscopic Partial Nephrectomy or laparoscopic Radical Prostatectomy following the surgeon criteria.
✓. Ability and willingness to comply with all study requirements to be evaluated for each study visit.
Exclusion criteria
✕. Pregnant or breastfeeding women at the time of the surgery.
✕. Subjects with severe concomitant illness that, at PI´s discretion, increases risk of therapeutic interventions or that have been submitted to multiple prior surgeries.
✕. Subjects admitted to the hospital due to an emergency situation.
✕. Subjects with untreated active infection.
✕. Subject with known allergy to some of the device components (i.e., stainless steel, etc.)
What they're measuring
1
Lack of occurrence of a SAE related to the use of the medical devices under investigation during the intervention